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The Effect of Home-based Exercise on Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity

Not Applicable
Completed
Conditions
Covid19
Breathing Exercise
Cardiovascular Diseases
Interventions
Behavioral: Second phase cardiac rehabilitation
Behavioral: Breathing and chest mobilization exercises
Registration Number
NCT05077943
Lead Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
Brief Summary

Objective propose: to investigate the effect of home based breathing exercise and chest mobilization on the cardiorespiratory functional capacity of Covid-19 survivors with cardiovascular comorbidity.

Breathing exercise and chest mobilization are proven to increase lung functional capacity in Covid-19 survivors. It is hypothesized that breathing exercise and chest mobilization in Covid-19 survivors will give benefits to Covid-19 survivors with cardiovascular disease.

Detailed Description

Lung restrictive disorder is one of the reasons that induce chronic fatigue in COVID-19 (Corona Virus Disease-19) survivors. It also gives a significant effect on cardiovascular patients who are in the second phase of cardiac rehabilitation. Breathing exercise and chest mobilization are proven to increase lung functional capacity in Covid-19 survivors. On the other hand, there is still no research that shows the effectiveness of Breathing exercises and chest mobilization in Covid-19 survivors who are suffering from cardiovascular problems.

Patients in National Cardiac Center Hospital, Jakarta, with a history of Covid-19 and have cardiovascular disease are recruited. They will undergo pre and post-exercise examinations such as blood sampling, do 6 minutes walking test, Peak Cough Flow and Peak Flow Rate test, measuring the chest dimension, treadmill, and answer the European Quality of Life Five Dimension (EQ-5D) questions. With randomization, patients will be determined to treatment or control group. They will be prepared about what exercises should they do at home. Subjects will be supervised digitally and regularly through Zoom meetings. Exercises will be done for 3 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
46
Inclusion Criteria
  • Patients who got infected by Covid-19 in 3 months before recruitment and suffering cardiovascular disease
  • Able to communicate and operate Youtube and Zoom.
Exclusion Criteria
  • Limitation to move any part of the body that causes the inability to do the instructed exercise.
  • Feel pain in extremities (visual analog scale >3)
  • Chronic Obstructive Pulmonary Disease
  • Neuromuscular disorder (stroke, peripheral neuropathy with significant motoric control disturbance
  • Musculoskeletal disorder (fracture, post amputation, severe arthritis in support joints)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
No Breathing ExerciseSecond phase cardiac rehabilitationPatients will do the second phase of cardiac rehabilitation for minimum 5 times per week, 30 minutes each time, in 3 months without being supervised
With Breathing ExerciseBreathing and chest mobilization exercisesPatients will do the second phase of cardiac rehabilitation for minimum 5 times per week, 30 minutes each time and breathing and chest mobilization exercise for 3 times per week. They will be supervised through online meetings.
Primary Outcome Measures
NameTimeMethod
Change of 6-minutes walking testChange from Baseline 6-minutes walking test at 3 months

To define initial ability to walk in 30 minutes for second phase cardiac rehabilitation (aerobic exercise). Unit of measure : meter

Change of Cardiac Exercise TestChange from Baseline Cardiac Exercise Test at 3 months

Patients walk on treadmill. Unit of measure : minutes, METs (Metabolic Equivalent of Task)

Change of Peak Cough Flow (PC)Change from Baseline Peak Cough Flow (PC) at 3 months

to define the functional capacity. Unit of measure : L/min.

Change of Peak Flow Rate (PFR)Change from Baseline Peak Flow Rate (PFR) at 3 months

to define the functional capacity. Unit of measure : L/min.

Secondary Outcome Measures
NameTimeMethod
Change of LymphocyteChange from Baseline Lymphocyte at 3 months

Lymphocyte (/µL)

Change of C-Reactive ProteinChange from Baseline C-Reactive Protein at 3 months

to determine infection markers. Unit of measure : mg/L

Change of Mean Corpuscular HemoglobinChange from Baseline Mean Corpuscular Hemoglobin at 3 months

Mean Corpuscular Hemoglobin (pg)

Change of NeutrophilChange from Baseline Neutrophil at 3 months

Neutrophil (/µL)

Change of HematocritChange from Baseline Hematocrit at 3 months

Hematocrit (%)

Change of Mean Corpuscular VolumeChange from Baseline Mean Corpuscular Volume at 3 months

Mean Corpuscular Volume (fL)

Change of PlateletChange from Baseline Platelet at 3 months

Platelet (thousand/µL)

Change of HemoglobinChange from Baseline Hemoglobin at 3 months

Hemoglobin (g/dL)

Change of ErythrocyteChange from Baseline Erythrocyte at 3 months

Erythrocyte (million/µL)

Change of European Quality of Life Five Dimension (EQ-5D)Change from Baseline EQ-5D at 3 months

1=have no problem, 2=have slight problem, 3=moderate problem, 4=severe problem, 5=unable to do. We will compare the points between pre and post exercise and looking the improvement.

Change of EosinophilChange from Baseline Eosinophil at 3 months

Eosinophil (/µL)

Change of MonocyteChange from Baseline Monocyte at 3 months

Monocyte (/µL)

Change of Mean Corpuscular Hemoglobin ConcentrationChange from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months

Mean Corpuscular Hemoglobin Concentration (%)

Change of Red Cell Distribution WidthChange from Baseline Red Cell Distribution Width at 3 months

Red Cell Distribution Width (%)

Change of LeucocyteChange from Baseline Leucocyte at 3 months

Leucocyte (/µL)

Change of D-dimerChange from Baseline D-dimer at 3 months

Unit of measure : ng/mL

Change of BasophilChange from Baseline Basophil at 3 months

Basophil (/µL)

Trial Locations

Locations (1)

National Cardiovascular Center Harapan Kita Hospital Indonesia

🇮🇩

Jakarta, Indonesia

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